ABSTRACT
Regulatory authorities publish data on the genotoxic potential of new drugs, which is necessary for the safety evaluation process. Pre-clinical studies are conducted to give an idea of the basic toxicological profile of new chemical entities (NCE). This data is used for the evaluation of the safety and efficacy of NCE, which, in turn, helps in the prediction of the drug’s likely risk and benefit assessment in New Drug Application (NDA) process. Genotoxicity assays, as an integral component of regulatory requirements, aim to evaluate the status of genotoxicity testing for pharmaceuticals, the variations in testing procedures and the role of the International Conference on Harmonization (ICH) for the adaptation of uniform guidelines. The scope of diverse test systems and the integration of novel test methods have been broadly discussed in this chapter. The new guidelines will facilitate improvement in the correctness of genotoxicity testing, which, in turn, will minimise the time required for such testing. This will help to safeguard the resources in the process of drug discovery and development.
